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DOI: 10.1055/s-0039-3403114
Effectiveness and safety of mepolizumab in real-world clinical practice: The REALITI-A study
Publikationsverlauf
Publikationsdatum:
28. Februar 2020 (online)
This abstract will be presented at ERS 2019 in Madrid, Spain.
Dr. Christina Hermsen is presenting this Encore on behalf of all authors with their permissions.
Background: Real-world evidence of mepolizumab use for severe eosinophilic asthma (SEA) in routine clinical practice will aid clinical decision making.
Aims: To assess mepolizumab effectiveness in patients (pts) with SEA in the real world.
Methods: REALITI-A is a 2y, global, prospective, single-arm, observational cohort study enrolling pts with SEA and newly prescribed mepolizumab 100 mg SC at physicianʼs discretion (no pre-defined eligibility criteria). Data were collected at routine healthcare visits; 1y pre-exposure data were collected retrospectively at enrolment. Primary endpoint was rate of clinically significant exacerbations (CSEs; requiring OCS and/or emergency room [ER] visit/hospitalisation). Exacerbations requiring ER visit/hospitalisation and maintenance OCS use were key secondary endpoints; treatment-related AEs were reported. This interim analysis includes pts with 1y post-exposure data.
Results: 368 treated pts were included (mean age, 53y; 62% female; geometric mean blood eosinophil count, 370 cells/µL; smoker: former/current 39%, never 61%; 70% on OCS). The rate ratio (RR) of CSEs was 0.31 (95%CI 0.27,0.35; 4.63 [pre-] reduced to 1.43 [post exposure] events/y); RR of exacerbations requiring hospitalisation/ER visits was 0.23 (0.18,0.30; 1.14 reduced to 0.27 events/y). OCS data were available for 159 (baseline) and 143 (Wk 53 – 56) pts. Median OCS dose reduced from 10 to 5 mg/day at Wk 53 – 56; 34% (49/143) stopped OCS. 53 (14%) pts had on-treatment AEs and 2 (< 1%) had serious AEs; there were no fatal AEs.
Conclusions: This study shows that significant reductions in exacerbations and OCS use with mepolizumab in clinical trials translate to a real-world setting.
Funding: GSK [204710]
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